CMS, OIG, DOJ, FTC Release New Interim and Final Rules on ACOs

Today, CMS released the final rule that will implement the Medicare Shared Savings Program (MSSP) mandated by section 3022 of the Affordable Care Act. Simultaneously, the Department of Justice’s Antitrust Division and the Federal Trade Commission released their joint “Statement of Antitrust Enforcement Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program” (Antitrust Policy Statement).

In response to the numerous comments, there are some significant differences between the proposed and the final rules, some of which were highlighted in today’s stakeholder call hosted by CMS Administrator Dr. Don Berwick, Jonathan Blum, Deputy Administrator and Director of the Center for Medicare, and Dr. Rick Gilfillan, Acting Director of the Innovation Center.

Additionally, CMS and the HHS-OIG provided an interim final rule on waivers of the application of the Stark Law, Anti-Kickback Statute, and certain civil monetary penalty provisions for ACOs participating in the MSSP, including those who become part of the Innovation Center’s Advance Payment Initiative. The public will be able to comment on the rule for 60 days after it is published in the Federal Register.

The Mintz team will follow up with our analysis of the MSSP’s final form and the potential impact of the waivers in upcoming posts and advisories.

Associate Editors

Mintz Levin’s Health Law Practice

As the health care and life sciences industries continue to undergo sweeping regulatory change, your company might be facing unprecedented structural and operational challenges. Heightened government scrutiny of industry practices certainly adds to the complexity of operating in the market for all providers, payors, manufacturers, distributors, and suppliers.Read More